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临床试验/NCT04242056
NCT04242056Unknown1 期

To Study the Pathophysiological Features of Multiple Sclerosis: Combined Multi-modalities of Amyloid and Tau Images Associated With Serum Neurofilament Light Chain Levels

Chang Gung Memorial Hospital0 个研究点目标入组 38 人开始时间: 2020年2月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
发起方
入组人数
38
主要终点
Correlation between hyperintensity lesions in FLAIR MRI and demyelination in amyloid PET image

研究概览

简要总结

Multiple sclerosis (MS) is the most common chronic inflammatory disease of the central nervous system1, whose demyelination is the pathological hallmark. MS is characterized by neuroinflammation, demyelination, axonal damage, and neurodegeneration2. The demyelination state in brain and the clinical course are difficult to predict in the early stage of disease. Recently, several neuroimaging and fluid biomarkers had been explored in MS. Using brain amyloid positron emission tomography (PET) in active MS had showed that both the damage sites and normal appearance white matter had a lower intensity than non-active MS. The result suggests a predictive role that the intensity from amyloid PET could reflect the disease activity and link to early myelin damage. The levels of tau protein in cerebrospinal fluid (CSF) had also been showed a negative correlation with brain atrophy, which is a prognostic marker for MS. In fluid biomarkers, both neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP) had been used in MS and reported correlations with disease severity, the extent of neuroinflammation and progression. In current study, investigator will enroll 38 participants with MS and evaluate their clinical severity; measure the WM lesion and disease activity by magnetic resonance imaging (MRI); myelination state and amyloid deposition by amyloid PET scan; tau deposition by state of-art tau PET scan. Investigator also measure the serum levels of NfL and GFAP as the index of axonal injury and disease activity. The relationship between disease severity, brain myelination, tau deposition and serum levels of NfL will be discuss.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 20-75 years old
  • Multiple Sclerosis patients

排除标准

  • Implantation of metal devices including cardiac pacemaker, intravascular metal devices.
  • Major systemic diseases including coronary arterial disease, heart failure, uremia, hepatic failure, prominent strokes, acute myocardial infarction, poorly controlled diabetes, previous severe head injury, intracranial operation, hypoxia, sepsis or severe infectious diseases.
  • Major psychiatric disorders, drug or alcohol abuse and major depression
  • Pregnant women or breast- feeding women.
  • Patients in whom MRI was contraindicated or patient had claustrophobia.
  • History of severe allergic or anaphylactic reactions particularly to the tested drugs.
  • History of positive test for human immunodeficiency virus (HIV).
  • Indication of impaired liver function as shown by an abnormal liver function profile at screening (eg. repeated values of aspartate aminotransferase [AST] and alanine aminotransferase [ALT] ≧ 3X the upper limit of normal values).

研究组 & 干预措施

Using image to diagnosis Multiple sclerosis (MS)

Other

In current study, we will enroll 38 patients with MS and evaluate their clinical severity; measure the WM lesion and disease activity by magnetic resonance imaging (MRI); myelination state and amyloid deposition by amyloid PET scan; tau deposition by state of-art tau PET scan

干预措施: 18F-PM-PBB3 (Drug)

结局指标

主要结局

Correlation between hyperintensity lesions in FLAIR MRI and demyelination in amyloid PET image

时间窗: 3 years

Investigator would be able to find the topographical correlation between hyperintensity lesions in FLAIR MRI and hypointensity lesions in amyloid PET, measurement by overlapping volume (ml) and overlapping ratio (%)

次要结局

  • Correlation between clinical parameters (EDSS) and hyperintensity lesions in FLAIR MRI and hyperintensity region of tau PET image light chain and GFAP levels.(3 years)
  • Correlation between clinical parameters (EDSS) and serum NfL levels(3 years)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hsu, Jung-Lung, MD

Associate Professor

Chang Gung Memorial Hospital

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